Multimodal Geriatric Pre-authorization Before Scheduled Orthopedic Surgery

NCT ID: NCT05062109

Last Updated: 2023-01-13

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-06-16
• Study Completion Date: 2023-12-31

Brief Summary

The main objective of this multicentric, prospective and interventional study is to assess the feasibility of multimodal prehabilitation in patients aged 75 years or older with surgical indication for coxarthrosis or severe gonarthrosis

Detailed Description

This study consists of a pre-established surgical preparation program in cooperation with physiotherapists or physical activity instructors, dieticians, psychologists, physical therapists and nurses.

This innovative program improves muscle strength, balance and walking of the study patients. It also allows for faster and better recovery of their physical fitness and intellectual abilities after surgery.

These interventions will be performed in day admission (DA) and at home and will consist of training, a diet program to strengthen the muscles and balance of the patients participating in the study.

Patients who agree to participate in the study will receive interventions for 6 weeks prior to surgery, partly in a day hospital and partly at home, including:

• Muscle rehabilitation developed with a physiotherapist or physical activity instructor
• Nutritional support (dietician at 1st, 3rd, and 6th day admission (DA), referring geriatrician)
• Cognitive and physical stimulation "Exergame" (Genious Healthcare); with only cognitive exercises at home
• Psychological support by a psychologist
• Information in the form of videos on the main risks and important points to know and prepare before and after surgery
• 1 follow-up call per week made by the PRE4OS referent between each day admission (DA) to assess patient satisfaction, any limitations encountered, possible exercises at home, the occurrence of possible adverse effects
• 1 hour per week home adapted physical activity session by the Siel Bleu association

Conditions

Osteoarthritis; Gonarthrosis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Multimodal geriatric prehabilitation

Group Type: EXPERIMENTAL

Multimodal geriatric prehabilitation

Intervention Type: BEHAVIORAL

Multimodal prehabilitation will be carried out over a period of 6 weeks in a day admission (once a week) and at home, and will include:

• Muscle rehabilitation developed with a physiotherapist or physical activity monitor
• Nutritional support (dietitian at the 1st, 3rd, and 6th day admission (DA))
• Cognitive and physical stimulation "Exergame"
• Psychological support by a psychologist
• Information in the form of videos on the main risks and important points to know and prepare before and after surgery
• Assessment of patient satisfaction, any limitations encountered, the possible performance of exercises at home and the occurrence of any adverse effects.
• One session of adapted physical activity at home of one hour per week by a physical trainer from the Siel Bleu association

Interventions

Multimodal geriatric prehabilitation

Multimodal prehabilitation will be carried out over a period of 6 weeks in a day admission (once a week) and at home, and will include:

• Muscle rehabilitation developed with a physiotherapist or physical activity monitor
• Nutritional support (dietitian at the 1st, 3rd, and 6th day admission (DA))
• Cognitive and physical stimulation "Exergame"
• Psychological support by a psychologist
• Information in the form of videos on the main risks and important points to know and prepare before and after surgery
• Assessment of patient satisfaction, any limitations encountered, the possible performance of exercises at home and the occurrence of any adverse effects.
• One session of adapted physical activity at home of one hour per week by a physical trainer from the Siel Bleu association

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Age ≥ 75 years
• Surgical indication for total hip or knee replacement for hip or knee osteoarthritis.
• Minimum time of 6 weeks between inclusion visit and date of surgery
• Physical (excluding coxarthrosis or knee osteoarthritis) and cognitive capacities to follow a prehabilitation program (assessment by the geriatrician)
• Proximity between place of life and hospital to go to the center for pre-rehabilitation
• Good understanding of the French language
• Benefiting from social coverage
• Have read the information notice and have consented to participate in the study by signing a written consent

Exclusion Criteria

• Urgent surgery (trauma, acute dislocation)
• Neurocognitive disorders at a moderate or severe stage (Mini Mental State Examination (M.M.S.E) ≤20), or not evaluable and not allowing to participate in the prehabilitation program
• Lack of social coverage (beneficiary or beneficiary)
• Adult persons subject to a legal protection measure (curatorship, guardianship and safeguard of justice)
• Refusal to participate
• Hospitalized patients ( the living space can be the home or thelon term care).

• Minimum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Gérond'if

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jacques Boddaert, MD PhD

Role: STUDY_CHAIR

Geriatric Perioperative Unit, Pitié-Salpêtrière hospital

Locations

Geriatric Perioperative Unit, Pitié-Salpêtrière hospital

Paris, IIe-de-France, France

Site Status: RECRUITING

Countries

France

Central Contacts

Isabelle Dufour

Role: CONTACT

isabelle.dufour@gerondif.org

+33 (0)185781010

Anaïs Cloppet, MD

Role: CONTACT

anais.cloppet@gerondif.org

+33 (0)185781010

Other Identifiers

2020-A03323-36

Identifier Type: -

Identifier Source: org_study_id